Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

Hypotrichosis Clinical Trial

Official title:

Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387906
• Other study ID #: Latisse2010
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2011
• Last updated: June 14, 2012
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Beer, Kenneth R., M.D., PA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Outpatient, female/male subjects of any race, 18-75 years of age.

• Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study

• Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or 2.

• Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region).

• Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.

• Written informed consent and written authorization for use or release of health and research information obtained.

• Willing to complete all required study visits, procedures, and evaluations including photography.

Exclusion Criteria:

• Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.

• Patients with any uncontrolled systemic disease

• Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis

• Patients with known or suspected trichotillomania disorder

• Patients with a history of glaucoma and/or increased ocular pressure

• Patients who are currently using an IOP-lowering prostaglandin analog (including Lumigan)

• Patients with a known hypersensitivity to bimatoprost or any other ingredient in Latisse

• Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).

• Patients with permanent eye and/or eyebrow make-up

• Any eyebrow tint or dye applications within 2 months prior to study entry

• Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows

• Participation in another investigational drug or device study within the last 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotrichosis

Intervention

Drug:
• topical bimatoprost
topical bimatoprost will be applied one drop to each eyebrow each night.

Locations

Country	Name	City	State
United States	Kenneth R. Beer, M.D. ,PA	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Beer	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. — View Citation

Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Latisse applied to the lateral and medial eyebrow	Increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.	10 months	No

External Links

•   eyebrows, bimatoprost, hypotrichosis